WE Medical B.V.

WE Medical B.V. specializes in single-use medical aids and accessories for stoma and wound care. Their portfolio includes skin barrier wipes designed to reduce irritation during stoma or wound management, adhesive removers for safe and residue-free removal of medical adhesives, a hydro flange extender for stoma applications, and a super-absorbent gelling agent for wound management. These products are developed to support hygiene, comfort, and ease of use in clinical settings.

WE Medical B.V. is based in the Netherlands. All of its devices fall under the EU’s medical device classification system, specifically Class I, which applies to low-risk devices like single-use wound care aids and adhesive removers. As Class I devices, they are subject to EU medical device regulations, including mandatory registration in the EUDAMED database to ensure compliance and traceability.

Yes, WE Medical B.V.’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU medical device legislation, allowing healthcare professionals and regulators to verify the device’s classification and market status.

WE Medical B.V.’s devices are classified as EU Class I medical devices. This classification is determined by their intended use and risk profile—such as single-use wound care aids, adhesive removers, and accessories for stoma management—which are considered low-risk under EU medical device regulations. Class I devices require compliance with basic safety and performance requirements but do not need pre-market clinical evaluations or notifying bodies for most cases.